Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds

The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.

Study Overview

• Status: Withdrawn
• Conditions: Lower Extremity Diabetic Leg Wounds; Lower Extremity Venous Leg Wounds; Lower Extremity Mixed Aetiology Leg Wounds
• Intervention / Treatment: Device: SNaP® Wound Care System

• Study Type: Observational

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XN
      • Section of Wound Healing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diabetic foot ulceration, venous or mixed aetiology lower limb ulceration who are receiving out-patient treatment from the Section of Wound Healing, Cardiff University, Wales.

Description

Inclusion Criteria:

• Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease).
• Wound present for >30 days.
• Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings.
• Patient is able to comply with study protocol requirements.
• Patient is able to understand and provide written consent.

Exclusion Criteria:

• Patient has evidence of wound infection in the opinion of the physician.
• Patient has a thick eschar that persists after wound debridement.
• Patient has an HbA1C >12%.
• Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis.
• Patient has untreated osteomyelitis.
• Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study.
• Patient is allergic to the wound care device or occlusive dressing.
• Patient has exposed blood vessels.
• Patient is pregnant or pregnancy is suspected.
• Patient is actively participating in other clinical trials that may interfere with their participation in this study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SNaP® Wound Care System	Device: SNaP® Wound Care System; Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wound Closure	12 weeks

Collaborators and Investigators

• Sponsor: KCI USA, Inc
• Collaborators: 3M

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 15, 2011
• First Posted (Estimated): August 16, 2011

Study Record Updates

• Last Update Posted (Actual): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 011711